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N-Force Screws Augmented With N-Force Blue in Hip Fractures (N-Force)

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ClinicalTrials.gov Identifier: NCT03807349
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.

Condition or disease Intervention/treatment Phase
Intracapsular Proximal Femur Fracture Garden Grade I Subcapital Fracture of Femoral Neck Garden Grade II Subcapital Fracture of Femoral Neck Device: N-Force Screws Augmented with N-Force Blue Not Applicable

Detailed Description:

Primary Endpoint:

• Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.

Secondary Endpoints:

  • Radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction.
  • Cost effectiveness

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
N-Force Screws
N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.
Device: N-Force Screws Augmented with N-Force Blue
N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)




Primary Outcome Measures :
  1. Re-operation Rate [ Time Frame: 12 months ]
    Re-operation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.


Secondary Outcome Measures :
  1. Radiographic Fracture Healing of the Intracapsular Femur (RUSH) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]
    Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).

  2. Radiographic Fracture Healing of the Intracapsular Femur (Steinberg Classification) [ Time Frame: 12 months ]

    Steinberg Classification is based on the radiographic appearance and location of lesion. It is concise and delineates the progression and extent of Avascular Necrosis (AVN) involvement more accurately.

    [stage 0:] normal or non-diagnostic radiographs, MRI and bone scan of at risk hip (often contralateral hip involved, or patient has risk factors and hip pain) [stage I:] normal radiograph, abnormal bone scan and/or MRI [stage II:] cystic and sclerotic radiographic changes [stage III:] subchondral lucency or crescent sign [stage IV:] flattening of femoral head, with depression graded into mild: <2 mm moderate: 2-4 mm severe: >4 mm [stage V:] joint space narrowing with or without acetabular involvement [stage VI]: advanced degenerative changes


  3. Clinical Fracture Healing of the Intracapsular Femur (FIX-IT) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]
    The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.

  4. Clinical Fracture Healing of the Intracapsular Femur (EQ-5D-5L) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]
    The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.

  5. Clinical Fracture Healing of the Intracapsular Femur (Harris Hip) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]
    This will be measured using Harris Hip Score. This is quantified on a scale of 0-100 and the domains covered are pain, function, absence of deformity, and range of motion. The score is quantified on a scale of 0-100, with 100 points being the best possible outcome. The domains cover pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).

  6. Clinical Fracture Healing of the Intracapsular Femur (Timed Up-and-Go) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]
    This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.

  7. Cost-Effective Analysis [ Time Frame: 12 months ]
    Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.



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Ages Eligible for Study:   61 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
  • Patient receives operative treatment within 7 days of injury.
  • Patient was ambulatory before injury.
  • Patient is older 61 years of age or older.

Exclusion Criteria:

  • Patient has Garden III or IV intracapsular proximal femur fracture.
  • Patient has major cognitive impairment (including dementia).
  • Patient is on dialysis.
  • Patient is not expected to survive follow-up schedule.
  • Patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (Investigator's discretion).
  • Patient is a prisoner.
  • Patient is known to be pregnant and/or breastfeeding.
  • Patient is a known alcohol or drug abuser.
  • Patient had previous/has active acute or chronic infections, especially at the site of operation.
  • Patient has non-viable bone, or has areas where surrounding bone is not viable or capable of supporting and anchoring the implant.
  • Patient has traumatic injuries with open wounds or close to the proximal femur fracture, which are likely to become infected.
  • Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
  • Physical conditions, in the opinion of the investigator, that would prohibit adequate implant support or impede healing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807349


Contacts
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Contact: Ryan Boylan 5743719784 ryan.boylan@zimmerbiomet.com

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Arlen Garcia    650-721-7613    agarci13@stanford.edu   
Contact: Natalie Tanner    650-721-7613    ntanner@stanford.edu   
Principal Investigator: Michael Gardner, MD         
Sub-Investigator: Julius Bishop, MD         
Sub-Investigator: Michael Bellino, MD         
United States, Illinois
Springfield Clinic Withdrawn
Springfield, Illinois, United States, 62703
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Jen Simmons    314-286-2984    j.simmons@wustl.edu   
Principal Investigator: Chris McAndrew, MD         
United States, Oregon
Donald B Slocum Research and Education Foundation Recruiting
Eugene, Oregon, United States, 97401
Contact: Erin Owen, PhD       erin.owen@slocumfoundation.org   
Principal Investigator: Daniel Fitzpatrick, MD         
Sub-Investigator: Daniel Sheerin, MD         
Sub-Investigator: David Weatherby, MD         
Sponsors and Collaborators
Zimmer Biomet

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03807349     History of Changes
Other Study ID Numbers: CMU2017-60T
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zimmer Biomet:
Cannulated Screws
Augmentation
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries